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NSF ANSI 363 Commenting Period
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Comments for The U.S. National ANSI NSF 363 Excipient GMP Standard are now being solicited. IPEC Americas GMP Committee is reviewing the Standard and will be providing comments via the link listed below. There will also be discussion about the standard in the final webinar of IPEC-Americas 2011 Webinar series that will take place on Tuesday, Dec. 20. There is still time to register for the webinar, click here to learn more. More



2011 Executive Committee Elections
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During the Dec. 7 Board of Trustees Annual Meeting in Washington, D.C., representatives of IPEC-Americas member companies voted to fill four Executive Committee offices which were up for election. See who was elected for three year terms of office beginning Jan. 1, and ending Dec. 31, 2014. More

IPEC-Americas Participates in USP/Department of Commerce Workshop for Chinese Government and Pharmacopeia Executives
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For the past five years on an annual basis, the United States Pharmacopeia has been hosting groups of as many as 30 representatives of the Chinese Pharmacopeia Commission and officials of provincial government drug control offices for several days of meetings in and around Washington, D.C. The purpose of the meetings is to share information on current pharmacopeial harmonization matters related to food, dietary supplements and pharmaceuticals, and also to provide training sessions for participants from both China and U.S. On Dec. 7, at USP's request, one of the workshops was hosted by the U.S. Department of Commerce at the Ronald Regan International Trade Center and featured several industry presentations. More

Views From Pharma Leaders: A Year in Review and a Look Forward
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Simply put, 2011 was a year of transition for bio/pharmaceutical companies, contract manufacturers and suppliers. Financial pressures caused by generic-drug incursion, the pressing need to augment R&D productivity and control costs and an increasingly global and complex supply chain are some of the key issues cited by executives participating in Pharmaceutical Technology's industry roundtable. More

IPEC Europe's Annual Meeting and EXCiPACT Launch
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IPEC Europe's 20th anniversary celebrations will take place on Jan. 26, at the Catalonia Berna Hotel in Barcelona, Spain, providing an opportunity not only to look ahead to the regulatory and scientific development affecting excipients at present and in the future, but also to reflect on how the sector has evolved over the last 20 years. A packed presentation program — entitled Looking Back, Moving Forward — will cover some of the most topical and pressing issues affecting users and manufacturers of excipients. More

FDA Rejects Citizen's Petition on Plan B
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After a week of arguments and protests, the FDA has denied a citizen's petition from the Center for Reproductive Rights on allowing greater access to generic versions of the Plan B contraceptive for girls under 17. The news comes after HHS Secretary Kathleen Sebelius' decision to trump the FDA on expanding access to the Plan B contraceptive. At issue was whether Teva Pharmaceutical Industries' product should be taken out from behind the pharmacists' counter, making it available outside pharmacy hours — and without a prescription for girls younger than 17 for the first time. More

3-Day Excipient GMP Auditing Workshop
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There are 18 spaces open. This popular workshop offers participants training in the assessment of excipient manufacturer conformance to appropriate GMP requirements. Training will analyze the essential elements of excipient good manufacturing practice for materials intended for use in pharmaceuticals or dietary supplements. The workshop will focus on excipient GMP compliance and attendees will learn auditing techniques, report writing, observation classification, etc. that relate to the manufacture of excipient ingredients. More

Dietary Supplement Use Increases As We Age
The Everyday Dietician via Health Goes Strong    Share    Share on FacebookTwitterShare on LinkedinE-mail article
More than one half of American adults take dietary supplements. Women are bigger users than men and the use of dietary supplements is steadily rising among those over age 60. If you are among the crowd that takes a daily multivitamin or any self-selected nutrient, herb or related product, there are some important guidelines you should follow. More

Endo Unveils Crush-Resistant Opioid
FiercePharma Manufacturing    Share    Share on FacebookTwitterShare on LinkedinE-mail article
The FDA has approved a new formulation of Endo Pharmaceuticals' opioid analgesic, Opana ER, that's intended to resist being crushed. Endo says in a statement that the tablets are based on a formulation technology from German pain specialist Grünenthal Group, a collaborator in the drug's development. The technology, called Intac, provides "tailor-made release properties to achieve bioequivalence" to pills based on more conventional and easily crushed formulations, Grunenthal says in its own statement. More

Federal Register Notice
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FDA is announcing the availability of a draft report entitled "Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review." A literature review was conducted to address a requirement of the Patient Protection and Affordable Care Act. FDA is publishing the literature review report to allow the public to provide comment on the report as it relates to the Affordable Care Act. More

EDQM Closed for Christmas and New Year
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EDQM News — The office of the EDQM will be closed for the Christmas/New Year period from Thursday afternoon, Dec. 22, until Monday, Jan. 2. Deadline for shipments of publications and reference standards: Click here.

Medicrime Convention - Thirteen countries join the Council of Europe Medicrime Convention. The presentations given at the Council of Europe Medicrime Convention conference held in Moscow, Russia, are now available to download: Click here.
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